Most antimicrobial drugs will no longer be over-the-counter; pharmaceuticals companies have three years to comply.

Dec 19, 2013

By dvm360.com staff

DVM360 MAGAZINE

Months of open meetings with veterinarians and food animal producers and deliberation with industry leaders and experts has led the U.S. Food and Drug Administration (FDA) to its final proposed rule to amend Veterinary Feed Directive regulations (VFD) to phase out antimicrobials for growth promotion in livestock. In an effort to avoid antimicrobial resistance, the rule will restrict use of antimicrobial drug use in animals only when medically important. The plan will also increase veterinary oversight of VFD drugs.

The FDA says it believes that the judicious use of medically important antimicrobial drugs should involve the oversight of a licensed veterinarian. Currently, most antimicrobial drugs approved for use in food-producing animals through their feed or water are available over-the-counter. Under the proposed rule, that will no longer be the case.

The final guidance requires animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on their product labels to remove production indications. Current over-the-counter antimicrobial drugs that will be prohibited for food production purposes by the final proposal would only be available under veterinary oversight for appropriate therapeutic uses. Pharmaceutical companies have three months to formally notify the FDA of compliance. Companies will then have a three-year window to meet the requirements of the new rule.

“Implementing this strategy is an important step forward in addressing antimicrobial resistance. The FDA is leveraging the cooperation of the pharmaceutical industry to voluntarily make these changes because we believe this approach is the fastest way to achieve our goal,” says Michael Taylor, FDA deputy commissioner for foods and veterinary medicine. “Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort.”

The FDA has the full support of the American Veterinary Medical Association (AVMA). The AVMA’s Steering Committee for FDA Policy on Veteirnary Oversight of Antimicrobials worked with the FDA on the final proposal. “The AVMA has long advocated that greater veterinary oversight of the use of antimicrobials on the farm is a benefit to human and animal health,” says AVMA President Clark Fobian, DVM. “The AVMA is ready to assist the U.S. Department of Agriculture (USDA) and the FDA in their outreach and communication efforts with stakeholders as we transition from the long history of these additives being available over the counter to the new VFD program.”

Notable aspects of the rule:

> Veterinary flexibility. The final rule is amended to provide greater flexibility for veterinarians by deferring to the veterinary profession and individual states for the specific criteria for acceptable veterinary professional conduct, rather than relying on a more rigid, one-size-fits-all, federal standard. From a practical standpoint, this enables the veterinary profession and individual states to adjust the specific criteria for a veterinarian-client-patient relationship (VCPR) to appropriately align with current veterinary practice standards, technological and medical advances and other regional considerations. This is intended to make it easier for veterinarians in remote geographical areas to more effectively provide services.

> Drug categories. The FDA proposes to revise the definition of category 2 to eliminate the automatic classification of VFD drugs into category 2. This would permit those medically important antimicrobials used in animal feed that are currently category 1 drugs to become VFD drugs consistent with FDA’s judicious use policy. At the same time, products containing these drugs would remain available through the current feed mill distribution system.

> Record keeping. VFD drug record keeping will align with current good manufacturing practices requirements for medicated feeds, thus taking record keeping from two years to one. The FDA stated in a release, “the value added by the second year of record retention has not been shown to justify the associated paperwork burden.”

> Animal health. The final rule removes the previous requirement to include the amount of feed with a VFD, instead veterinarians will provide approximate number of animals, duration and level of drug in feed.

To submit comments regarding FDA’s final proposal, go to regulations.gov. Electronic and written comments must be submitted by March 12, 2014. To see a list of drugs affected by the proposal, go to fda.gov.